QMSR will align FDA's medical device quality management system with ISO 13485:2016. It will be released by the end of this year and become effective one year later. This harmonization is expected to save medical device companies at least $439 million over the next decade.

On 7 November 2024, ECHA added one substance to the SVHC Candidate List, bringing it to 242 entries at that time. Review the applicable communication and reporting duties, and check ECHA’s current list for updates.

The EU extended transitional deadlines for qualifying legacy in vitro diagnostic devices in 2024. Eligibility depends on device history, manufacturer actions and class-based dates; importers should verify the evidence before relying on an extension.

A look back at the European Commission’s 2024 Q&A guidance on extended IVDR and MDR transition periods, including legacy-device conditions, evidence of eligibility and changes during transition.

In 2017, the FDA initiated MRAs with EU and UK, for human drugs. On May 30th, the FDA once again signed an MRA, with 16 EU countries, this time concerning veterinary drugs.

EU AI Act is to be the world's first AI law. European Parliament passed the draft on June 14. However, it faced opposition from industry organizations like MedTech Europe, the Confederation of European Business, and Team-NB (European Association for Medical Devices Notified Bodies).

A look at the EU MDR transition extension discussed in 2023, including the 2027 and 2028 deadlines, eligibility conditions and why the regulation itself was not postponed. Check current official guidance before relying on a deadline for a specific device.

The EU’s common-charger rules cover specified categories of radio equipment, not every electronic or healthcare device. This article explains the scope and why blood pressure monitor manufacturers should check each product’s classification before assuming USB-C is required.